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Trial registered on ANZCTR


Registration number
ACTRN12617000803392
Ethics application status
Approved
Date submitted
29/05/2017
Date registered
1/06/2017
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
HYPES: Peanut allergy desensitisation using sequential hypoallergenic and roasted peanuts
Scientific title
HYPES: can sequential desensitisation with hypoallergenic and roasted peanuts improve safety and efficacy of peanut oral immunotherapy treatment in children.
Secondary ID [1] 292055 0
Nil
Universal Trial Number (UTN)
Trial acronym
HYPES (HYpoallergenic Peanuts Eaten Safely)
Linked study record
A pilot study was conducted to determine the safety and efficacy of boiled followed by roasted peanut therapy. ACTRN12614000919617

Health condition
Health condition(s) or problem(s) studied:
Peanut allergy 303458 0
Condition category
Condition code
Inflammatory and Immune System 302867 302867 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children aged 6-18 with a clear positive history of peanut allergy and have a SPT greater than or equal to 8 mm, or a psIgE of greater than 15 kU/L will be treated with a 3-step desensitisation protocol. Step 1: 12 weeks graded dose treatment with 12-hour heat treated hypoallergenic peanut; Step 2: 20 weeks graded dose treatment with 2-hour heat treated hypoallergenic peanut; Step 3: 20weeks graded dose treatment with roasted peanuts. Maintenance dose at completion of desensitisation is 12 roasted peanuts daily. The raw peanuts are heated in water in a custom designed apparatus at a sub-boiling temperature. Quality control of the treated peanuts will be employed to ensure appropriate hypoallergenic status for 2-hour and 12-hour heat treated peanuts.

Phase 1, The starting dose is 63 mg per day of 12-hour heat treated peanuts and increases weekly over 12 weeks to 2g twice a day.
Phase 2. The starting dose is 63 mg per day of 2-hour heat treated and increases weekly over 20 weeks to 6g twice daily.
Phase 3. The starting dose is 31.5 mg per day of defatted roasted peanut powder and increases weekly over 20 weeks to 6g twice daily.

The first 2 increments of each step are packaged in capsules, the contents of which are emptied onto a spoon of yoghurt. The remaining doses are eaten as fractions or intact peanuts and eaten at breakfast and their evening meal.
The subjects will receive a treatment diary which is required to be recorded daily. In addition, the capsules/nuts will be retrieved and measured at the end of each phase before starting the next phase.
Intervention code [1] 298184 0
Treatment: Other
Comparator / control treatment
No control group will be employed.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302259 0
The percentage of subjects who can tolerate 12 roasted peanuts without allergic reaction at the completion of treatment. This will be assessed by an oral food challenge with 12 roasted peanuts.
Timepoint [1] 302259 0
56-60 weeks
Primary outcome [2] 302263 0
The percentage of subjects who experience adverse events other than oral itch as a consequence of treatment including: urticaria and angioedema, allergic rhinitis or conjunctivitis, gastrointestinal symptoms such as abdominal pain, vomiting or diarrhoea, respiratory symptoms including cough, wheeze or respiratory distress, fainting and anaphylaxis. Adverse events will be recorded on a treatment diary and on a separate adverse event report. Subjects are required to immediately report any serious adverse events or any event that requires treatment. Subjects will also be contacted monthly to monitor progress.
Timepoint [2] 302263 0
56-60 weeks
Secondary outcome [1] 335312 0
Percentage of subjects who can tolerate 63 mg of 2-hour heat treated peanut without reaction. This is the first dose of phase 2 and will be administered under supervision of an allergist. Any reaction will be observed and recorded by the allergist.
Timepoint [1] 335312 0
12 weeks
Secondary outcome [2] 335313 0
Percentage of subjects who can tolerate 63 mg of roasted peanut without reaction. This is the first dose of phase 3 and will be administered under supervision of an allergist. Any reaction will be observed and recorded by the allergist.
Timepoint [2] 335313 0
32 weeks

Eligibility
Key inclusion criteria
Subjects who have a clear positive peanut-allergic history that includes ingestion of peanut, to be followed immediately by such reactions as rashes, angioedema, vomiting, abdominal pain, rhino-conjunctivitis, cough or wheeze. They must also have either a skin prick test reading of equal to or greater than 8 mm, or a psIgE level of greater than 15kU/L, or both.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of a severe anaphylactic reaction to peanut as defined by hypotension, collapse, loss of consciousness, hypoxia or ever needing three or more doses of intramuscular adrenaline or and intravenous infusion for management of an allergic reaction.
2. Children with serious medical co-morbidities (e.g. severe asthma), or if there are concerns about psychosocial readiness of the child to participate in the study.
3. Contraindication to skin prick test e.g. diffuse dermatological conditions, severe dermatographism, or child unable to cease antihistamines.
4. The child or parents/guardians of the child object to have blood tests performed.
5. Children with parents/guardians who are unable to provide adequate supervision and adherence to the study protocol, or are unable to complete follow-up.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcomes are efficacy of treatment and prevalence of adverse events. Data will be analysed on an intention-to-treat basis, using two-sided tests with p<0.05 considered significant. The difference in the proportion of children experiencing an adverse event in this study compared to historical data will be assessed using a single proportion test, assuming a binomial distribution. Planned sub-group analysis will be undertaken to assess the effects of child characteristics (i.e. severity of peanut allergy, sex) on primary and secondary outcomes. SPSS version 20 will be used for analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/06/2017
Actual
27/07/2017
Date of last participant enrolment
Anticipated
15/05/2018
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
75
Accrual to date
71
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 16239 0
5067 - Beulah Park

Funding & Sponsors
Funding source category [1] 296588 0
Charities/Societies/Foundations
Name [1] 296588 0
Channel 7 Children's Research Foundation
Country [1] 296588 0
Australia
Primary sponsor type
Individual
Name
Dr Tim Chataway
Address
Department of Human Physiology
School of Medicine
University Drive
Flinders University
Bedford Park
South Australia, 5042
Country
Australia
Secondary sponsor category [1] 295540 0
Individual
Name [1] 295540 0
Prof Kevin Forsyth
Address [1] 295540 0
Department of Paediatrics and Child Health
School of Medicine
University Drive
Flinders University
Bedford Park
South Australia, 5042
Country [1] 295540 0
Australia
Other collaborator category [1] 279584 0
Individual
Name [1] 279584 0
Dr Billy Tao
Address [1] 279584 0
Department of Paediatrics and Child Health
School of Medicine
University Drive
Flinders University
Bedford Park
South Australia, 5042
Country [1] 279584 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297809 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 297809 0
Office for Research
Flinders Medical Centre
Ward 6C, Room 6A219
Flinders Drive, Bedford Park,
SA, 5042
Ethics committee country [1] 297809 0
Australia
Date submitted for ethics approval [1] 297809 0
01/12/2016
Approval date [1] 297809 0
09/01/2017
Ethics approval number [1] 297809 0
431.16

Summary
Brief summary
Peanut allergy affects up to 3% of infants in Australia and only 20% may outgrow their allergy. There is no approved treatment for peanut allergy although oral desensitisation shows promise. Research studies to date show high rates of adverse adverse events making existing protocols unsuitable for standard clinical practice.

We have investigated and subsequently published the effect of heated water treatment on peanuts which reduces their allergenicity. We have produced for this trial two types of hypoallergenic peanuts: very low (12-hour treatment), and low allergenicity (2-hour treatment).

We have also completed a pilot study which suggests that hypoallergenic peanuts have reduced capacity to cause adverse events and thus provide increased safety for desensitisation with roasted peanuts.

Our hypothesis is that sequential treatment with very low allergenic peanut followed by low allergenic peanut will provide partial desensitisation for allergic subjects. This partial desensitisation will allow subsequent desensitisation with roasted peanut without significant adverse events.

We will test this hypothesis by treating at least 66 peanut allergic children with HYPES (Hypoallergenic Peanuts Eaten Safely) protocol which utilises 3 phases of treatment, 12-hour heat treated peanut followed by 2-hour heat treated peanut and finally roasted peanuts over a combined total of 52 weeks. We will test the effectiveness of this treatment while monitoring adverse events, psIgE, IgG4 and skin prick test results.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75162 0
Dr Tim Chataway
Address 75162 0
Dept Human Physiology
School of Medicine
University Drive
Flinders University
Bedford Park
South Australia, 5042
Country 75162 0
Australia
Phone 75162 0
+61 882043108
Fax 75162 0
+61 882045768
Email 75162 0
[email protected]
Contact person for public queries
Name 75163 0
Dr Tim Chataway
Address 75163 0
Dept Human Physiology
School of Medicine
University Drive
Flinders University
Bedford Park
South Australia, 5042
Country 75163 0
Australia
Phone 75163 0
+61 882043108
Fax 75163 0
+61 882045768
Email 75163 0
[email protected]
Contact person for scientific queries
Name 75164 0
Dr Tim Chataway
Address 75164 0
Dept Human Physiology
School of Medicine
University Drive
Flinders University
Bedford Park
South Australia, 5042
Country 75164 0
Australia
Phone 75164 0
+61 882043108
Fax 75164 0
+61 882045768
Email 75164 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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